NCT06845163Befejeződött2. fázis

Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema

Clinical Study on the Efficacy of Oral Dapagliflozin Combined With Intravitreal Injection of Anti-Vascular Endothelial Growth Factor in Patients With Diabetic Macular Edema

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 26.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

The purpose of this clinical study is to explore the efficacy of dapagliflozin as an adjunct to intravitreal anti-vascular endothelial growth factor (anti-VEGF) for enhanced reduction of retinal thickness and vision improvement in patients with diabetic macular edema. The main question the study aims to answer is: Does dapagliflozin reduce the thickness of the macula when combined with the standard of care intravitreal anti-VEGF therapy more than the intravitreal anti-VEGF therapy alone?

Állapot (regiszter): Befejeződött
Fázis (regiszter): 2. fázis
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 56 (tényleges)
Első benyújtás: 2025. febr. 20.
Kezdés: 2025. febr. 8.
Elsődleges befejezés: 2026. júl. 14.
Fő szponzor: Alexandria University
Betegségek: Diabéteszes retinopátia
NCT-szám: NCT06845163

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó · 2. fázis
Bevont résztvevők: 56
2025. febr. 8. és az elsődleges befejezés (2026. júl. 14.) között
1 helyszín, 1 országban
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Type II diabetes mellitus patients, treated with premixed insulin and metformin, and diagnosed with center-involved diabetic macular edema (CiDME)
Presence of retinal thickening involving the center of the fovea (CiDME) in the study eye on Optical Coherence Tomography (OCT) Heidelberg Spectralis; If both eyes are eligible, the eye with the greater central subfield thickness on OCT is selected as the study eye.
Decreased visual acuity primarily attributable to DME
Clear ocular media and pupillary dilation for adequate retinal imaging
Ability to understand the study procedures and willingness to provide written informed consent
- Study participant exclusion criteria:
Patients below 18 years old and patients above 85 years old
Patients with type I diabetes mellitus (Insulin dependent diabetes mellitus IDDM)
Pregnant women and lactating women diagnosed with diabetes or intending to become pregnant in the next 12 months
Patients who had myocardial infarction within 3 months prior to screening
Patients who had transient ischemic attack (TIA), ischemic or hemorrhagic stroke within 3 months prior to screening
Patients with poorly controlled diabetes mellitus, defined as patients having glycosylated hemoglobin (HbA1c) level of ≥12% at screening or patients who were hospitalized for diabetic ketoacidosis or hyperosmolar coma within 4 months prior to screening
Patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at screening
Patients with severe hepatic impairment of Child-Turcotte-Pugh class C at screening
Patients treated with antidiabetic drugs thiazolidinediones (TZD) (rosiglitazone and pioglitazone) prior to screening
Patients who were receiving SGLT2 inhibitors (e.g., dapagliflozin, canagliflozin, or empagliflozin) within 3 months prior to screening
Known allergy or hypersensitivity to any component of the study drugs
Current or previous participation in another clinical study involving the systemic or ocular administration of an investigational drug or device within 6 months of screening
- Study eye exclusion criteria:
Macular edema caused by other conditions than diabetic macular edema or coexisting with DME such as retinal vein occlusion, choroidal neovascularization (CNV), or uveitic cystoid macular edema
History of postoperative cystoid macular edema (Irvine-Gass syndrome)
Cataract extraction within 3 months prior to screening
Patients who had previous macular laser treatment
Patients who had peripheral panretinal photocoagulation laser (PRP) treatment within 6 months prior to screening
Patients who have been treated with intravitreal anti-VEGF or intravitreal corticosteroids within 6 months prior to screening
The use of corticosteroids or non-steroidal anti-inflammatory eye drops within 1 month prior to screening
Patients on topical prostaglandin analogs (e.g., latanoprost, travoprost, ioprost, or tafluprost) at screening
History of vitrectomy or scleral buckling
Presence of diffuse vitreomacular traction or thick epiretinal membrane on OCT causing significant traction
Presence of tractional retinal detachment involving the macula and requiring vitrectomy
Presence of other associated macular pathology (e.g., macular scars or macular holes) on OCT
Presence of rubeosis iridis
Signs of hypertensive retinopathy (arterioral spasm or silver wiring of blood vessels)
Presence of glaucoma
Aphakia
Yttrium aluminum garnet (YAG) laser capsulotomy within 3 months prior to screening
Patients diagnosed with ocular surface infections until treated prior to receiving the intravitreal injections
- Non-study eye exclusion criteria:
The non-study eye receiving simultaneous intravitreal anti-VEGF treatment with the study eye

Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
Alexandria Main University Hospital, The Ophthalmology Department, Faculty of Medicine, Alexandria University	Alexandria	Egyiptom	Ismeretlen állapot

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